Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA finalizes cybersecurity guidance in push to secure devices from hackers

The FDA announced that it has finalized its guidance on managing cybersecurity risks as it aims to protect patient privacy and prevent devices from malfunctioning due to computer viruses.

Judge won't toss dinner-party kickback claims against Novartis

Note to sales reps: You might think twice about inviting the same doctors to the same speaker events over and over. Particularly when those events involve pricey dinners at Nobu and Smith & Wollensky.

Warning to Gilead, AbbVie and BMS: France has a new tax for pricey hep C meds

European countries are known for wresting price cuts from drugmakers. Usually, it's a straightforward cost-effectiveness argument. But France has come up with a new strategy: Arm-twisting taxes.

FDA spotlights innovation in 3-D imaging

Breast cancer detection may soon leave 2-D mammography in the dust, embracing instead a more comprehensive diagnostic tool: 3-D technology.

Novartis dinner-party kickback case must go on, judge says

In an order filed Tuesday, U.S. District Judge Paul Gardephe refused to dismiss claims that Novartis lavished entertainment on certain physicians in return for increased prescriptions.

Allergan's drug-delivering eye implant gets expanded indication from FDA

Allergan announced that the FDA has approved the company's Ozurdex sustained-release biodegradable implant to treat diabetic macular edema (DME). The expanded indication means the therapy, based on a proprietary delivery system, is approved for use in the general DME population, not just those with an artificial lens implant or in need of cataract surgery. 

Trinity Biotech expects FDA submission in early 2015 for heart failure Dx

Ireland's Trinity Biotech gained a CE mark for its new heart failure point-of-care diagnostic and is now turning its sights toward the U.S. regulatory process within the next few months.

Salix's Relistor has its chance to get a jump on AZ's new constipation med

Salix Pharmaceuticals nabbed the new Relistor approval it was counting on. The FDA blessed the injectable drug as a treatment for all patients with constipation caused by opioid pain relievers, boosting its target market more than tenfold.

Study: Publicly available information about 510(k) devices' safety and effectiveness lacking

A study published Sept. 29 in The Journal of the American Medical Association concluded that publicly available information to support the safety and effectiveness of implanted, 510(k)-cleared devices is lacking.

Homemade medical devices present both challenges and opportunities

Nightscout touts itself as an open source, do-it-yourself project to enable remote monitoring of blood glucose levels of patients with Type 1 diabetes.